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Randomisation in trials: do potential trial participants understand it and find it acceptable?
C Kerr1, E Robinson, A Stevens
1Department of Psychology, Keele University, UK. c.e.p.kerr@keele.ac.uk
Journal of Medical Ethics
|February 12, 2004
Summary
Lay persons can identify some random allocation methods but find them unacceptable in clinical trials. Justifying randomisation, especially computer allocation, improves acceptability.
Area of Science:
- Clinical Trials
- Health Research Methodology
- Patient Engagement
Background:
- Understanding random allocation is crucial for informed consent in clinical trials.
- Lay perceptions of randomisation methods can influence trial participation and trust.
Purpose of the Study:
- To assess the public's ability to identify random allocation methods.
- To evaluate the acceptability of random allocation methods in clinical trial contexts.
Main Methods:
- Participants (n=130) evaluated hypothetical scenarios with various allocation methods.
- Judgements on randomness and acceptability were recorded for medical and non-medical contexts.
- The impact of scientific justification on acceptability was examined.
Main Results:
- Most participants correctly identified non-random methods (e.g., preference) and random methods (e.g., computer, coin toss, hat draw).
- Acceptability of correctly identified random methods was low in clinical trial scenarios.
- A scientific justification significantly increased the acceptability of computer-based random allocation.
Conclusions:
- While lay persons understand some random allocation concepts, acceptability remains a challenge.
- Clear justifications for randomisation, particularly for computer allocation, are essential for patient trust and participation.
- Current guidelines' recommended computer allocation wording appears warranted but needs justification.